Primary Outcomes

Secondary Outcomes

Measure

Rates of adverse events associated with treatment

time frame:
2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Biopsy-confirmed* invasive head and neck cancer, including the following primary
sites:
- Nasopharynx
- Oropharynx
- Paranasal sinus
- Oral cavity
- Orbit
- Salivary gland NOTE: *Biopsy must be performed prior to initiation of external
beam radiotherapy (EBRT)
- Stage T2-4 tumor at the time of diagnosis
- Primary tumor ≤ 5 cm in diameter at the time of CyberKnife® stereotactic
radiosurgery (SRS)
- Meets one of the following criteria:
- Eligible for CyberKnife® SRS as boost therapy, as defined by one of the
following criteria:
- Planning to undergo definitive EBRT, with or without chemotherapy, with
curative intent for primary head and neck cancer
- Biopsy-confirmed locally persistent disease < 3 months after completion of
definitive EBRT
- Eligible for CyberKnife® SRS as salvage therapy*, as defined by one of the
following criteria:
- Biopsy-confirmed locally recurrent disease occurring ≥ 6 months after the
completion of radiotherapy; achieved a complete response to initial therapy
by imaging or clinical examination; had > 50% of the tumor volume in the
prior irradiated volume; and received > 45 Gy of radiotherapy
- Biopsy-confirmed locally recurrent disease occurring between 6 weeks and 6
months after the completion of radiotherapy; achieved a complete response
to initial therapy by imaging or clinical examination; had < 50% of the
tumor volume in the prior irradiated volume; and received > 45 Gy of
radiotherapy NOTE: *Not a candidate for salvage surgery or brachytherapy
- Anticipated total dose of radiotherapy to the spinal cord ≤ 50 Gy (including prior
dose)
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to achieve normal tissue tolerance to critical structures with the CyberKnife®
planning system
- Able to undergo CT simulation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion Criteria:
- No laryngeal or hypopharyngeal cancer
- No evidence of distant metastases
- No prior brachytherapy
- No prior CyberKnife® SRS boost or salvage therapy
- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix
- No active connective tissue disorders (e.g., lupus or scleroderma)

Additional Information

Official title

The Feasibility and Outcome of Cyberknife® Stereotactic Radiosurgical Boost and Salvage Therapy for Head and Neck Cancer

Principal investigator

Minh T. Truong, MD

Description

OBJECTIVES:
- To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery
as boost therapy after standard chemoradiotherapy in patients with locally advanced
head and neck cancer.
- To determine the feasibility and tolerability of CyberKnife® stereotactic radiosurgery
as salvage therapy in patients with locally recurrent head and neck cancer.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to disease status after
prior standard therapy. Patients with residual disease after standard therapy are assigned
to group 1. Patients with recurrent disease ≥ 6 months after standard therapy are assigned
to group 2.
All patients undergo placement of 3-6 gold fiducial markers within 1-2 weeks of beginning
CyberKnife® stereotactic radiosurgery (SRS) treatment.
- Group 1 (CyberKnife® SRS boost therapy): Patients undergo CyberKnife® SRS boost therapy
(2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
- Group 2 (CyberKnife® SRS salvage therapy): Patients undergo CyberKnife® SRS salvage
therapy (5 fractions) 3 times weekly.
After completion of study treatment, patients are followed periodically for up to 2 years.

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Trial Details

Related Tags

A type of external radiation therapy that uses special equipment to position the patient and precisely deliver radiation to a tumor. The total dose of radiation is divided into several smaller doses given over several days. Stereotactic radiation therapy